Randomized Double Blind Placebo Controlled Trial of the Steroid Sparing Effect of Xolair (Omalizumab) in Patients With Persistent Eosinophilic Bronchitis
Overview
- Phase
- Phase 2
- Intervention
- Placebo
- Conditions
- Steroid and/or Prednisone Dependent Asthma
- Sponsor
- McMaster University
- Enrollment
- 11
- Locations
- 5
- Primary Endpoint
- Magnitude of the reduction in the dose of corticosteroid from week 12 to week 32.
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
The purpose of this study is to investigate whether addition of Omalizumab enables a reduction in the dose of prednisone in patients with asthma and eosinophilic bronchitis.
This will be a double-blind placebo-controlled, 3-centre, randomized parallel group trial divided into two sequential study periods.
Period 1: After establishing the minimum dose of prednisone to maintain asthma control and maintain sputum eosinophils <3%, subjects will be randomized to either placebo or Omalizumab for 16 weeks (either once monthly for 4 months or every 2 weeks for 4 months).
Period 2: standardised prednisone reduction at intervals of 4-weeks until there is a clinical and eosinophilic exacerbation or bothersome steroid withdrawal effects. If patients have an exacerbation, they will be treated with prednisone. This patient will continue on Omalizumab or placebo during the entire duration of the study but not continue the phase of steroid reduction.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Omalizumab (Xolair)
Dosage/frequency is dependent on body weight (kg) and baseline blood IgE level.
Intervention: Placebo
Placebo (Normal Saline)
0.9% normal saline equivalent to the dosage/frequency/duration of Omalizumab
Intervention: Omalizumab (Xolair)
Outcomes
Primary Outcomes
Magnitude of the reduction in the dose of corticosteroid from week 12 to week 32.
Time Frame: From Week 12 to Week 32
Proportion of patients with change in absolute % count of sputum eosinophil week 0 to week 12, and week 12 to week 32
Time Frame: From Week 0 to Week 12 and Week 12 to week 32
Secondary Outcomes
- Blood eosinophils(From Week 0 to week 32)
- Forced Expired Volume in 1 second (FEV1)(From Week 0 to Week 32)
- Fraction of exhaled nitric oxide (FeNO)(From Week 0 to Week 32)
- Asthma Control Questionnaire(From Week 0 to Week 32)
- Ratio of Forced Expired Volume in 1 second to Forced Vital Capacity (FEV1/VC)(From Week 0 to Week 32)
- Provocative concentration causing a 20% drop in FEV1 (PC20)(From Week 0 to Week 32)
- change in % sputum eosinophil(From Week 0 to Week 32)